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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-002624-28
    Sponsor's Protocol Code Number:FIT-EU-04
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-10-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2014-002624-28
    A.3Full title of the trial
    A Multi-center, Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption due to GI Immaturity in Preterm Infants.
    Étude multicentrique, en double aveugle, randomisée et contrôlée par placebo visant à évaluer l'efficacité et la tolérance du NTRA-2112 sur la malabsorption intestinale due à une immaturité du système digestif chez des nourrissons prématurés.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To assess the efficacy of NTRA-2112 on intestinal malabsorption due to gastro-intestinal immaturity by measuring the time required to reach full enteral feeding in preterm infants during the treatment period compared to a placebo formulation.
    Evaluer l'efficacité du NTRA-2112 sur la malabsorption intestinale due à une immaturité du système digestif en mesurant le temps nécessaire chez des nourrissons prématurés pour atteindre une alimentation orale complète pendant la période de traitement en comparaison avec un placebo.
    A.3.2Name or abbreviated title of the trial where available
    A Study to Assess the Efficacy and Safety of NTRA-2112 in Preterm Infants
    A.4.1Sponsor's protocol code numberFIT-EU-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02510560
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNutrinia
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNutrinia
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSermes UK Limited
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address1 Paper Mews, 330 High Street
    B.5.3.2Town/ cityDorking, Surrey
    B.5.3.3Post codeRH4 2TU
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailignazio@sermesuk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code NTRA-2112
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral powder in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Malabsorption intestinale due à une immaturité du système digestif chez des nourrissons prématurés.
    E.1.1.1Medical condition in easily understood language
    Preterm infants have an under-developed gastrointestinal tract.
    The final Insulin concentration obtained with NTRA-2112 is physiological and within the range present in human breast milk.
    Les nourrissons prématurés ont un tractus intestinal sous-développé.
    La concentration finale en insuline obtenue avec le NTRA-2112 est physiologique (semblable à celle retrouvée dans le lait humain).
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10025479
    E.1.2Term Malabsorption syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10025476
    E.1.2Term Malabsorption
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of NTRA-2112 on intestinal malabsorption due to GI immaturity by the time required to reach full enteral feeding in preterm infants during the treatment period as compared to placebo.
    Évaluer l'efficacité du NTRA-2112 sur la malabsorption intestinale due à une immaturité du système digestif par le délai nécessaire pour atteindre une alimentation entérale complète chez des nourrissons prématurés durant la période de traitement comparativement au placebo.
    E.2.2Secondary objectives of the trial
    - To assess the effect of NTRA-2112 on number of days to achieve discharge from hospital or readiness to discharge (based on predefined criteria) as compared to placebo
    - To assess the effect of NTRA-2112 on the number of days to end gastric residuals over 2ml/measurement as compared to placebo
    - To assess the effect of NTRA-2112 on growth parameters compared to placebo
    - To assess the effect of NTRA-2112 on number and percentage of infants to reach complete enteral feeding within 6, 8 and 10 days from treatment initiation
    - Évaluer l'effet du NTRA-2112 sur le nombre de jours nécessaires pour que les nourrissons puissent sortir de l’hôpital ou soient prêts à sortir (en fonction de critères prédéfinis) par rapport au placebo
    - Evaluer l'effet du NTRA-2112 par rapport au placebo sur le nombre de jours nécessaires pour que les résidus gastriques de plus de 2 ml par mesure disparaissent
    - Evaluer l'effet du NTRA-2112 sur les paramètres de croissance comparativement au placebo
    - Evaluer l'effet du NTRA-2112 sur le nombre et le pourcentage de nourrissons atteignant une alimentation entérale complète dans les 6, 8 et 10 jours suivant le début du traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pre-term infants 26 and up to 32 weeks gestation.
    2. Birth weight ≥ 500 gr.
    3. Postnatal age up to 5 days.
    4. Fraction of inspired oxygen ≤ 0.60 at enrolment.
    5. The infant is in a cardiovascular stable condition.
    6. Infant is able to take enteral feed.
    7. No heart and chest compression or any resuscitation drugs given to the infant during delivery.
    8. Patient is expected to wean off PN at the primary hospital.
    9. Informed consent form signed by parents or legal guardian.
    10. In the Investigator’s opinion, is able to comply with the trial requirements.
    1. Nourrissons prématurés avec un âge gestationnel de 26 à 32 semaines.
    2. Poids à la naissance ≥ 500 g.
    3. Âge postnatal de 5 jours maximum.
    4. Fraction d'oxygène dans l'air inspiré ≤ 0,60 au moment de l'inclusion.
    5. Le nourrisson est dans un état cardio-vasculaire stable.
    6. Le nourrisson peut recevoir une alimentation entérale.
    7. Aucune compression cardiaque et thoracique pratiquée ou aucun médicament de réanimation administré au nourrisson pendant l'accouchement.
    8. Le patient devra être sevré de la nutrition parentérale à l’hôpital principal.
    9. Formulaire de consentement éclairé signé par les parents ou le tuteur légal.
    10. De l'avis de l'investigateur, capacité à se conformer aux exigences de l'essai.
    E.4Principal exclusion criteria
    1. Complete enteral feeding.
    2. Major congenital malformation – Infants with genetic, metabolic or endocrine disorder diagnosed before enrolment.
    3. High index of suspicion of infection before enrolment.
    4. Intra Uterine Growth Retardation (IUGR) defined as weight for gestational age <p3. Weight for gestational age <p10 + Doppler abnormalities in utero.
    5. Confirmed NEC.
    6. Maternal diabetes (Type I/II or gestational).
    7. The infant is treated with Insulin.
    8. NPO, nothing per os for any reason at the study entry.
    9. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
    10. Participation in another interventional clinical study that may interfere with the results of this trial.
    11. In the Investigator’s opinion, is not able to comply with the trial requirements.
    1. Alimentation entérale complète.
    2. Malformation congénitale importante - Nourrissons présentant des troubles génétiques, métaboliques ou endocriniens diagnostiqués avant l'inclusion.
    3. Indice élevé de suspicion d'infection avant l'inclusion.
    4. Retard de croissance intra-utérin (RCIU) défini par un poids en fonction de l’âge gestationnel inférieur au 3ème percentile (P3). Poids en fonction de l’âge gestationnel inférieur au 10ème percentile (P10) + anomalies au doppler in utero.
    5. Entérocolite nécrosante néonatale (ENN) confirmée.
    6. Diabète maternel (de type I/II ou gestationnel).
    7. Le nourrisson est traité avec de l'insuline.
    8. Aucune administration per os pour quelque raison que ce soit à l’inclusion.
    9. Compression cardiaque et thoracique pratiquée ou médicaments de réanimation administrés au nourrisson pendant l'accouchement.
    10. Participation à une autre étude clinique interventionnelle pouvant interférer avec les résultats de cet essai.
    11. De l'avis de l'investigateur, incapacité à se conformer aux exigences de l'essai.
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of days to achieve complete enteral feeding (NFE) defined by: number of days to achieve enteral feeding of 150 cc/kg/day for at least 3 consecutive days; note that the NFE will be computed until the first of the three consecutive days.
    Nombre de jours pour atteindre une alimentation entérale complete; l'alimentation entérale complète se définit par la capacité des nourrissons prématurés à atteindre une alimentation entérale de 150 ml/kg/jour pendant 3 jours consécutifs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 days.
    Jusqu'à 28 jours.
    E.5.2Secondary end point(s)
    Number of days to discharge from the hospital or readiness-for discharge, whichever occurs first.
    Readiness-for-Discharge is defined by meeting all the criteria enumerated below:
    1. Infant weight ≥ 1800 g
    2. Stable body temperature
    3. Readiness for oral feeding
    Nombre de jours nécessaires pour sortir de l’hôpital ou être prêt à sortir de l'hôpital, selon la première de ces éventualités.
    Le nourrisson est prêt à sortir de l’hôpital lorsque tous les critères ci-dessous sont satisfaits :
    1. Poids du nourrisson ≥ 1 800 g
    2. Température corporelle stable
    3. Maturité pour alimentation orale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 months.
    Jusqu'à 3 mois.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Israel
    Italy
    Netherlands
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 300
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 300
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Babies
    Bébés
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard nutrition.
    Alimentation standard.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-01-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-04-25
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